VAERS Reports U7260AA

VAERS 2644593

SANOFI PASTEUR · HIB (ACTHIB) · Charge U7260AA

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Staat: MD
Alter: 0,6
Geschlecht: F
Eingang: 13.06.2023
Impfdatum: 17.05.2023
Beginn: 17.05.2023
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: SYR / RL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja

Expired product administered

Symptomtext

On May 17th, 2023 patient came into the clinic for her 6 month well child visit and received multiple vaccines one of which was an Expired vaccine, was given in the right thigh. There was no treatment needed for this, no injury occured.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Expired product administered
Hospital-Tage: -
Labordaten: none
Aktuelle Erkrankungen: none
Vorgeschichte: none
Andere Medikamente: no medications
Allergien: NKDA
Vorherige Impfungen: -

VAERS 2616529

SANOFI PASTEUR · HIB (ACTHIB) · Charge U7260AA

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Staat: WA
Alter: 0,9
Geschlecht: M
Eingang: 18.04.2023
Impfdatum: 06.04.2023
Beginn: 06.04.2023
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: OT / LL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Expired product administered

Symptomtext

administered an ACTHIB last week and the diluent expired 30mar2023 with no reported adverse event; Initial information received on 12-Apr-2023 regarding an unsolicited valid non-serious case received from a physician. This case involves a 11 months old male patient to whom an HIB (PRP/T) vaccine [ACT-HIB] was administered last week with expired diluent with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) concomitant(s) and family history were not provided. On 06-Apr-2023, the patient received 0.5 ml (dose 4) of suspect HIB (PRP/T) vaccine with expired diluent, powder and solvent for solution for injection (Lot number Diluent: U7260AA; expiry date: 30-Mar-2023 and lot number Powder: UJ652AA; expiry date- 04-Apr-2023) (strength: standard) via intramuscular route in the left thigh for immunization with no reported adverse event (expired product administered) (latency: same day). No lab data were reported. Action taken: not applicable. At time of reporting, the outcome was Unknown for the event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Expired product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2613441

SANOFI PASTEUR · HIB (ACTHIB) · Charge U7260AA

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Staat: OR
Alter: 1,3
Geschlecht: M
Eingang: 12.04.2023
Impfdatum: 04.04.2023
Beginn: 04.04.2023
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: OT / LL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Expired product administered Medication error No adverse event

Symptomtext

patient received two expired vaccines with no reported adverse event; Initial information was received on 05-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 16 months old male patient who experienced patient received two expired vaccines with no reported adverse event while receiving vaccines diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] and hib (prp/t) vaccine [ACT-HIB]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13). On 04-Apr-2023, the patient received a 4th dose of 0.5ml suspect hib (prp/t) vaccine lot U7260AA expiry date: 30-MAR-2023 via intramuscular route in the left thigh for Immunization. On 04-Apr-2023, the patient received a 4 dose of suspect diphtheria-15/tetanus/5 ac pertussis vaccine lot number not reported via intramuscular route in the left thigh for Immunization. On 04-Apr-2023 the patient developed a non-serious event of patient received two expired vaccines with no reported adverse event (expired product administered) following the administration of hib (prp/t) vaccine and following the administration of diphtheria-15/tetanus/5 ac pertussis vaccine. Action taken with haemophilus type b (hib) vaccine (ACT-HIB) and DIPHTHERIA, TETANUS and acellular pertussis vaccine (Daptacel) was not applicable. It was not reported if the patient received a corrective treatment for the event (patient received two expired vaccines with no reported adverse event). At time of reporting, the outcome was Unknown for the event patient received two expired vaccines with no reported adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Expired product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: PREVNAR 13
Allergien: -
Vorherige Impfungen: -

VAERS 2440305

SANOFI PASTEUR · HIB (ACTHIB) · Charge U7260AA

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Staat: GA
Alter: 0,5
Geschlecht: M
Eingang: 12.09.2022
Impfdatum: 01.09.2022
Beginn: 01.09.2022
Tage bis Beginn: 0,0
Dosis: 4
Route/Site: OT / LL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Extra dose administered

Symptomtext

extra dose of ACTHIB was administered to a patient with no reported adverse event; Initial information received on 01-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old male patient to whom extra dose of acthib was administered with no reported adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 01-Sep-2022, the patient received 0.5 mL dose of suspect HIB (PRP/T) VACCINE (formulation and strength not reported; lot U7260AA, expiry date: 30-Mar-2023) via intramuscular route in the left vastus lateralis for prophylactic immunization. On 01-Sep-2022, (latency: same day) the patient had extra dose of acthib was administered to a patient with no reported adverse event (extra dose administered) following the administration of HIB (PRP/T) VACCINE. It was reported, "An extra dose of ACTHIB was administered to a 6 month old male patient. This was ACTHIB dose number four in the series. The patient received their third dose of ACTHIB on 11Aug2022". Action taken was not applicable. At time of reporting, the outcome was Unknown for the event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Extra dose administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -